# K021574: TM2000 Fetaltrace Transtelephonic Receiving Center

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Aug 12, 2002 after 90 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992164 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013879: TM2000, Model 1, Card Guard Scientific Survival, Ltd. (2002) Summary page 4.

## Indications for use
The TM2000 FetalTrace Telemedicine Receiving Center is intended for supporting transtelephonic monitoring of the Fetal/Maternal parameters of patients.

Source page: https://510kreport.com/device/K021574
Methodology: https://510kreport.com/methodology